Background: The safety of an infant formula containing a new mixture of the prebiotics galacto-oligosaccharides (GOS) and fructo-oligosaccharide (FOS) and the probiotic Lactobacillus reuteri needs to be evaluated.
Methods: Healthy term infants in Singapore were randomly assigned (using computer-generated allocation sequences) to receive exclusively an experimental infant formula containing L. reuteri, GOS (5.